Baxano Completes Enrollment in Lumbar Spinal Stenosis Study

In short

Back in March we covered the CE marking of Baxano’s clever iO-Flex® spinal decompression system. Now the company has announced it has completed enrollment in its post-market clinical performance evaluation of the company’s flagship surgical system for decompressing patients diagnosed with moderate to severe lumbar spinal stenosis.

Background

The Baxano iO-Flex System is the first minimally invasive set of flexible instruments allowing surgeons to target lumbar stenosis in the central canal, lateral recess, and neural foramen with minimal disruption to the patient’s healthy anatomy critical for maintaining spinal stability. It is the only treatment alternative that allows surgeons to decompress up to four nerve roots through a single laminotomy.

Positive outcomes from an interim analysis of the data were presented by neurosurgeon Lawrence Dickinson, MD at the American Association of Neurological Surgeons meeting last month. These preliminary results demonstrated patients had a decrease in leg and back pain with a clinical improvement in low back function. In addition, patients treated with the iO-Flex System have thus far experienced shorter surgical times and decreased hospital length of stay compared to published clinical data.

Baxano will continue to follow all patients in the study for up to two years and collect the clinical outcomes to further support the economic value the new technology offers healthcare. Inadequately addressing lateral recess and foraminal stenosis in patients with lumbar stenosis have been reported as the number one cause of poor surgical outcomes.

Clinician comments

“Patients are experiencing rapid, pronounced improvement in symptoms. Importantly, the surgical response has been sustained,” reported San Francisco/Bay Area neurosurgeon Lawrence Dickinson, MD, one of the study’s lead investigators. “When compared to historical controls, preliminary results suggest patients treated with the iO-Flex System are experiencing shorter hospital stays, less blood loss, and fewer complications.”

“The iO-Flex System provides surgeons a new option to thoroughly address lumbar spinal stenosis without compromising the stabilizing structures of the spine,” said Sumeer Lal, MD, a neurosurgeon from Greenville, South Carolina. “For some patients, I have been able to reduce the need — and therefore cost — of spinal implants required for their procedures and I have also been able to send them home sooner. These results are very promising for patients suffering from lumbar spinal stenosis.”